Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Therapeutic efficacy between capsule and tablet
Study Overview
Brief Summary
A manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost all of them as therapeutic categories.
One of the products and ursodeoxycholic acid, commercially known as Ursacol, a bile acid physiologically present in human bile, approved by Agência Nacional de Vigilância Sanitária (ANVISA), among several indications, for the treatment of the symptomatic form of primary biliary cholangitis, autoimmune etiology and predominant incidence in female.
This is a prospective, cross-over, interventional and open-label study, where patients attending the inclusion and exclusion criteria are attended by the Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHC-FMUSP) Pharmacy Division in the Pharmaceutical Care sector.
As patient information as well as the prescribed drugs, compiled by a data collection instrument from the ICHC-FMUSP Pharmacy Division and a semi-structured questionnaire.
Detailed Description
The therapeutic efficacy of Ursodeoxycholic Acid 300 mg tablet and capsules was measured comparing the liver enzyme parameters: alkaline phosphatase, gamma glutamyl transferase, alanine aminotransferase, aspartate aminotransferase and total bilirubin in three times: before treatment begins, in the middle of treatment and at the end of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Primary biliary cholangitis (PBC) was diagnosed when at least two of the following three criteria: histologically proven early stage PBC; positive Anti-mitochondrial antibody (AMA) (titer >1:40) and alkaline phosphatase >1.5 times upper limit of normal at any time since diagnosis.
- •Patients had to be on ursodeoxycholic acid for at least 6 months.
- •Patients should be able to understand and ready to sign the informed consent form.
Exclusion Criteria
- •Patients not adherent to treatment with reference medicine.
- •Known intolerance to the study drugs.
- •Patients who withdrew their agreement.
Arms & Interventions
capsule
pharmaceutical form: capsule ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months
Intervention: Ursodeoxycholic Acid 300mg capsule (Drug)
tablet
pharmaceutical form: tablet ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months
Intervention: Ursodeoxycholic Acid 300mg tablet (Drug)
Outcomes
Primary Outcomes
Therapeutic efficacy between capsule and tablet
Time Frame: up to 12 months
Compare the liver enzyme parameters (alkaline phosphatase, alanine aminotranferase, aspartate aminotransferase, gamma glutamyl transferase and total bilirubin) in three different moments:before the treatment, between the treatment and at the end of treatment.
Secondary Outcomes
No secondary outcomes reported
Investigators
Cleuber Esteves Chaves
Principal Investigator
University of Sao Paulo General Hospital